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Experimental study of periodontitis and rheumatoid arthritis

Efficacy of therapeutic management of periodontitis on the clinical manifestations of rheumatoid arthritis: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79186420
Enrollment
40
Registered
2012-03-20
Start date
2011-12-01
Completion date
Unknown
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis and periodontitis Musculoskeletal Diseases Rheumatoid arthritis, unspecified and chronic periodontitis

Interventions

A rheumatologist will assess periodontal and RA parameters at the first visit (V1), then the participants will be randomly assigned to one of two groups to receive immediate or delayed periodontal tre

Sponsors

University Hospital of Toulouse (CHU de Toulouse) (France)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female, aged 18 years or older 2. Rheumatoid arthritis diagnosed since at least one year 3. Disease Activity Score (DAS 28) score between 3.2 and 5.1 4. No change to medication, dosage or formulation in RA treatment during the 3 months before the inclusion visit 5. At least six natural teeth with root 6. Subject with periodontitis, defined by the presence of one site with periodontal probing depth = 4 mm and clinical attachment level = 3 mm on at least 4 teeth 7. Subject able to understand and willing to provide written informed consent in French 8. Subject affiliated to the security system

Exclusion criteria

Exclusion criteria: 1. Acute oral infection, acute oral pain (including pulpitis), suspicious oral mucosal lesion, severe oral inflammation unrelated to periodontal conditions, or need for immediate tooth extractions 2. Planned hospitalization within 4 months after the screening visit 3. One or more known infectious diseases [Human immunodeficiency virus(HIV), hepatitis, infectious mononucleosis] 4. Known clinically significant renal disease (creatinine clearance <60 ml/min), or liver disease 5. Unbalanced diabetes 6. Known risk of endocarditis 7. Have a permanent pacemaker 8. Antithrombotic treatment 9. Severe difficulties in understanding written and spoken French 10. Pregnant, lactating, or plans to become pregnant during the study 11. Chronic disorder that requires chronic or intermittent use of antibiotics 12. Hypersensitivity to chlorhexidine gluconate 13. Participation in another study with an investigational compound 14. Contraindications to both amoxicillin and clindamycin 15. Contraindications to dental local anesthetic

Design outcomes

Primary

MeasureTime frame
Difference between 3-month and baseline DAS 28 scores

Secondary

MeasureTime frame
Difference between 3-month and baseline values of the following: 1. American College of Rheumatology (ACR) scores 2. Health Assessment Questionnaire (HAQ) scores 3. General Oral Health Assessment Index (GOHAI) scores 4. Periodontal Inflamed Surface Area (PISA)

Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 22, 2026